LIFE SAVING DRUG SHORTAGE ACT House SponsorsRep. Jack D. Franks-Rita Mayfield, La Shawn K. Ford and Silvana Tabares Senate Sponsors(Sen. Pamela J. Althoff and Julie A. Morrison) 8/16/2013HousePublic Act . . . . . . . . . 98-0355 New Act Creates the Life-Saving Drug Shortage Prevention Act. Provides that a notification to the Director of Public Health shall be required from a manufacturer of a drug concerning a discontinuance, interruption, or adjustment of the manufacture of a drug that would likely result in a shortage. Provides that the notification shall be required at least 6 months prior to the date of the discontinuance or planned interruption or adjustment, and in the case of any other interruption or adjustment a notification shall be required as soon as possible. Provides that the Director may modify the time frames. Provides that the Director shall implement evidence-based criteria for identifying drugs that may be vulnerable to a shortage, and sets forth certain criteria. Sets forth provisions concerning public notification. Effective immediately.House Committee Amendment No. 1 Deletes reference to:New ActAdds reference to:225 ILCS 120/200 newReplaces everything after the enacting clause. Amends the Wholesale Drug Distribution Licensing Act. Sets forth a definition of "drug in shortage". Provides that any person engaged in the wholesale distribution of a drug in shortage must be licensed by the Department of Financial and Professional Regulation. Provides that the provision concerning licensure shall not apply to entities within the normal distribution channel as defined under the Act. Provides that, except with regard to the return of drugs, it is unlawful for any person, other than those licensed as a manufacturer, a manufacturer's exclusive distributor, or an authorized distributor of record, to purchase or receive a drug in shortage from any person not licensed by the Department. Provides that a person found to have violated a provision concerning drugs in shortage shall be subject to administrative fines, orders for restitution, and orders for disgorgement. Requires the Department to (1) create a centralized, searchable database of those entities licensed to sell or distribute a drug in shortage, including manufacturers, wholesale distributors, and pharmacy distributors, to enable purchasers of a drug in shortage to easily verify the licensing status of an entity offering such drugs; (2) establish a system for reporting the suspected instances of unscrupulous conduct by distributors of a drug in shortage to the Office of the Attorney General; and (3) adopt rules to carry out the provisions concerning drugs in shortage. Effective immediately.Correctional Note, House Committee Amendment No. 1 (Dept of Corrections) There are no penalty enhancements associated with this bill. The bill would have no fiscal or population impact on the Department. Pension Note, House Committee Amendment No. 1 (Government Forecasting & Accountability) HB 84 (H-AM 1) will have no fiscal impact on any pension fund or retirement system in Illinois.Judicial Note, House Committee Amendment No. 1 (Admin Office of the Illinois Courts) This bill would neither increase nor decrease the number of judges needed in the State.Balanced Budget Note, House Committee Amendment No. 1 (Office of Management and Budget) HB 84 (H-AM 1) will have an approximate one-time fiscal impact of $200,000 to create the database along with an approximate annual cost of $1,050,000 for six employees and related operational costs. Current application and renewal fees for wholesale drug distributors are $200 for a two-year license. The Department estimates that there will be 1,240 new entities required to get this license which adds revenues of $248,000 for each two year period. With the projected amount of revenue falling well short of the required expenditures to properly enforce the requirements of this amendment and the uncertainty of other fines and fees related to the regulation of the wholesale distribution of drugs in shortage; it is thought that this amendment will have a negative impact and the budget would not be balanced. Home Rule Note, House Committee Amendment No. 1 (Dept. of Commerce & Economic Opportunity) HB 84 (H-AM 1) does not pre-empt home rule authority. State Mandates Fiscal Note, House Committee Amendment No. 1 (Dept. of Commerce & Economic Opportunity) HB 84 (H-AM 1) does not create a State mandate. State Debt Impact Note, House Committee Amendment No. 1 (Government Forecasting & Accountability) HB 84 (H-AM 1) would not change the amount of authorization for any type of State-issued or State-supported bond, and, therefore, would not affect the level of State indebtedness. Fiscal Note, House Committee Amendment No. 1 (Dept. of Public Health) The fiscal impact of HB 84 (H-AM 1) to the Department of Public Health is unknown. Senate Committee Amendment No. 1 Replaces everything after the enacting clause. Reinserts the language of the engrossed bill. Changes the definition of "drug in shortage". Provides that any person engaged in the wholesale distribution of a drug in shortage in the State (previously was a drug in shortage without reference to the State) must be licensed by the Department of Financial and Professional Regulation. Provides that, except with regard to the return of drugs, it is unlawful for any person, other than a manufacturer, a manufacturer's exclusive distributor, a third party logistics provider, or an authorized distributor of record, to purchase or receive a drug in shortage from any person not licensed by the Department (previously did not include third party logistics providers). Requires the Department to (1) create a centralized, searchable database of those entities licensed to engage in wholesale distribution (previously to "sell or distribute a drug in shortage"), including manufacturers, wholesale distributors, and pharmacy distributors, to enable purchasers of a drug in shortage to easily verify the licensing status of an entity offering such drugs; (2) establish a system for reporting the suspected instances of unscrupulous conduct by distributors of a drug in shortage to the Office of the Attorney General; and (3) adopt rules to carry out the provisions concerning drugs in shortage. Effective immediately.Senate Floor Amendment No. 2 Provides that the Department of Financial and Professional Regulation shall establish a system for reporting the reasonable suspicion that a violation of the Act has been committed by a distributor (was previously "suspected instances of unscrupulous conduct") by distributors of a drug in shortage to the Office of the Attorney General and the appropriate State's Attorney's office (previously excluded the State's Attorney).Senate Floor Amendment No. 3 Provides that nothing in the provisions related to drugs in shortage prohibits hospital pharmacies from purchasing or receiving a drug in shortage from another hospital pharmacy in the event of a medical emergency. 1/8/2013HousePrefiled with Clerk by Rep. Jack D. Franks 1/9/2013HouseFirst Reading 1/9/2013HouseReferred to Rules Committee 1/29/2013HouseAdded Co-Sponsor Rep. La Shawn K. Ford 1/30/2013HouseAssigned to Human Services Committee 2/21/2013HouseAdded Co-Sponsor Rep. Silvana Tabares 3/7/2013HouseAdded Chief Co-Sponsor Rep. Rita Mayfield 3/7/2013HouseChief Co-Sponsor Changed to Rep. Rita Mayfield 3/11/2013HouseHouse Committee Amendment No. 1 Filed with Clerk by Rep. Jack D. Franks 3/11/2013HouseHouse Committee Amendment No. 1 Referred to Rules Committee 3/13/2013HouseHouse Committee Amendment No. 1 Rules Refers to Human Services Committee 3/20/2013HouseHouse Committee Amendment No. 1 Adopted in Human Services Committee; by Voice Vote 3/20/2013HouseDo Pass as Amended / Short Debate Human Services Committee; 015-000-000 3/20/2013HousePlaced on Calendar 2nd Reading - Short Debate 3/21/2013HouseHouse Committee Amendment No. 1 Fiscal Note Requested as Amended by Rep. Jack D. Franks 3/21/2013HouseHouse Committee Amendment No. 1 State Mandates Fiscal Note Requested as Amended by Rep. Jack D. Franks 3/21/2013HouseHouse Committee Amendment No. 1 Balanced Budget Note Requested as Amended by Rep. Jack D. Franks 3/21/2013HouseHouse Committee Amendment No. 1 Correctional Note Requested as Amended by Rep. Jack D. Franks 3/21/2013HouseHouse Committee Amendment No. 1 Home Rule Note Requested as Amended by Rep. Jack D. Franks 3/21/2013HouseHouse Committee Amendment No. 1 Judicial Note Requested as Amended by Rep. Jack D. Franks 3/21/2013HouseHouse Committee Amendment No. 1 Pension Note Requested as Amended by Rep. Jack D. Franks 3/21/2013HouseHouse Committee Amendment No. 1 State Debt Impact Note Requested as Amended by Rep. Jack D. Franks 3/21/2013HouseHouse Committee Amendment No. 1 Correctional Note Filed as Amended 3/22/2013HouseHouse Committee Amendment No. 1 Pension Note Filed as Amended 3/22/2013HouseHouse Committee Amendment No. 1 Judicial Note Filed as Amended 3/28/2013HouseHouse Committee Amendment No. 1 Balanced Budget Note Filed as Amended 4/4/2013HouseHouse Committee Amendment No. 1 Home Rule Note Filed as Amended 4/4/2013HouseHouse Committee Amendment No. 1 State Mandates Fiscal Note Filed as Amended 4/8/2013HouseHouse Committee Amendment No. 1 State Debt Impact Note Filed as Amended 4/8/2013HouseHouse Committee Amendment No. 1 Fiscal Note Filed as Amended 4/10/2013HouseSecond Reading - Short Debate 4/10/2013HousePlaced on Calendar Order of 3rd Reading - Short Debate 4/11/2013HouseThird Reading - Short Debate - Passed 113-000-000 4/11/2013SenateArrive in Senate 4/11/2013SenatePlaced on Calendar Order of First Reading April 12, 2013 4/11/2013SenateChief Senate Sponsor Sen. Pamela J. Althoff 4/12/2013SenateFirst Reading 4/12/2013SenateReferred to Assignments 4/23/2013SenateAssigned to Licensed Activities and Pensions 5/1/2013SenatePostponed - Licensed Activities and Pensions 5/7/2013SenateSenate Committee Amendment No. 1 Filed with Secretary by Sen. Pamela J. Althoff 5/7/2013SenateSenate Committee Amendment No. 1 Referred to Assignments 5/7/2013SenateSenate Committee Amendment No. 1 Assignments Refers to Licensed Activities and Pensions 5/8/2013SenateSenate Committee Amendment No. 1 Adopted 5/9/2013SenateDo Pass as Amended Licensed Activities and Pensions; 009-000-000 5/9/2013SenatePlaced on Calendar Order of 2nd Reading May 14, 2013 5/14/2013SenateSenate Floor Amendment No. 2 Filed with Secretary by Sen. Pamela J. Althoff 5/14/2013SenateSenate Floor Amendment No. 2 Referred to Assignments 5/14/2013SenateSecond Reading 5/14/2013SenatePlaced on Calendar Order of 3rd Reading May 15, 2013 5/14/2013SenateSenate Floor Amendment No. 2 Assignments Refers to Licensed Activities and Pensions 5/15/2013SenateSenate Floor Amendment No. 3 Filed with Secretary by Sen. Pamela J. Althoff 5/15/2013SenateSenate Floor Amendment No. 3 Referred to Assignments 5/15/2013SenateSenate Floor Amendment No. 3 Assignments Refers to Licensed Activities and Pensions 5/16/2013SenateSenate Floor Amendment No. 2 Recommend Do Adopt Licensed Activities and Pensions; 007-000-000 5/16/2013SenateSenate Floor Amendment No. 3 Recommend Do Adopt Licensed Activities and Pensions; 007-000-000 5/17/2013SenateAdded as Alternate Co-Sponsor Sen. Julie A. Morrison 5/23/2013SenateRecalled to Second Reading 5/23/2013SenateSenate Floor Amendment No. 2 Adopted; Althoff 5/23/2013SenateSenate Floor Amendment No. 3 Adopted; Althoff 5/23/2013SenatePlaced on Calendar Order of 3rd Reading 5/23/2013SenateThird Reading - Passed; 056-001-000 5/23/2013HouseArrived in House 5/23/2013HousePlaced on Calendar Order of Concurrence Senate Amendment(s) 1, 2, 3 5/24/2013HouseSenate Committee Amendment No. 1 Motion Filed Concur Rep. Jack D. Franks 5/24/2013HouseSenate Floor Amendment No. 2 Motion Filed Concur Rep. Jack D. Franks 5/24/2013HouseSenate Floor Amendment No. 3 Motion Filed Concur Rep. Jack D. Franks 5/24/2013HouseSenate Committee Amendment No. 1 Motion to Concur Referred to Rules Committee 5/24/2013HouseSenate Floor Amendment No. 2 Motion to Concur Referred to Rules Committee 5/24/2013HouseSenate Floor Amendment No. 3 Motion to Concur Referred to Rules Committee 5/28/2013HouseSenate Committee Amendment No. 1 Motion to Concur Rules Referred to Human Services Committee 5/28/2013HouseSenate Floor Amendment No. 2 Motion to Concur Rules Referred to Human Services Committee 5/28/2013HouseSenate Floor Amendment No. 3 Motion to Concur Rules Referred to Human Services Committee 5/29/2013HouseSenate Committee Amendment No. 1 Motion to Concur Recommends Be Adopted Human Services Committee; 015-000-000 5/29/2013HouseSenate Floor Amendment No. 2 Motion to Concur Recommends Be Adopted Human Services Committee; 015-000-000 5/29/2013HouseSenate Floor Amendment No. 3 Motion to Concur Recommends Be Adopted Human Services Committee; 015-000-000 5/30/2013HouseSenate Committee Amendment No. 1 House Concurs 117-000-000 5/30/2013HouseSenate Floor Amendment No. 2 House Concurs 117-000-000 5/30/2013HouseSenate Floor Amendment No. 3 House Concurs 117-000-000 5/30/2013HouseHouse Concurs 5/30/2013HousePassed Both Houses 6/19/2013HouseSent to the Governor 8/16/2013HouseGovernor Approved 8/16/2013HouseEffective Date August 16, 2013 8/16/2013HousePublic Act . . . . . . . . . 98-0355